Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
CriticalFDA
Alere San Diego, Inc.
Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 010...
Diagnostic Devices·77,342 affected·Dec 5, 2014
CriticalFDA
Alere San Diego, Inc.
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System...
Diagnostic Devices·231,967 affected·Dec 5, 2014
CriticalFDA
Abdallah Candies, Inc
Abdallah Milk Chocolate Bites CARAMEL, Net Wt 4.5 oz. (127g), UPC 7 6668407116 2, Ingredients: Pure milk chocolate (sugar, chocolate liq...
Dairy·330 affected·Dec 4, 2014
High RiskFDA
Willy's Inc
Willy's Just Peachy Salsa, packaged in 16-oz. plastic deli containers
Food·1,944 affected·Dec 4, 2014
CriticalFDA
Baxter Healthcare Corp
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Pr...
Injectable Drugs·542,080 affected·Dec 4, 2014
Medium RiskFDA
K C Pharmaceuticals Inc
Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Astringent Red...
Ophthalmic Drugs·302,976 affected·Dec 4, 2014
Medium RiskFDA
K C Pharmaceuticals Inc
Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottl...
Ophthalmic Drugs·427,512 affected·Dec 4, 2014
Medium RiskFDA
K C Pharmaceuticals Inc
Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Best Choice, DISTRIBUTED BY: VALU MERCHA...
Ophthalmic Drugs·751,440 affected·Dec 4, 2014
RecallFDA
Micro Labs Usa, Inc S
Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micr...
Oral Drugs·13,488 affected·Dec 4, 2014
RecallFDA
K C Pharmaceuticals Inc
Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Lab...
Ophthalmic Drugs·71,904 affected·Dec 4, 2014
RecallFDA
Micro Labs Usa, Inc S
Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: ...
Oral Drugs·240 affected·Dec 4, 2014
RecallFDA
Micro Labs Usa, Inc S
Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micr...
Oral Drugs·13,464 affected·Dec 4, 2014
CriticalFDA
Teleflex, Inc.
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is ...
Surgical Devices·18 affected·Dec 4, 2014
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Be...
Medical Devices·2,155 affected·Dec 4, 2014
High RiskFDA
Ev3, Inc.
ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high r...
Medical Implants·24 affected·Dec 4, 2014
High RiskFDA
Zimmer, Inc.
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable ...
Medical Implants·83 affected·Dec 4, 2014
High RiskFDA
Baxter Corporation Englewood
Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. E...
Medical Devices·54,000 affected·Dec 4, 2014
High RiskFDA
Zimmer Manufacturing B.v.
Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use i...
Medical Devices·68 affected·Dec 4, 2014
High RiskFDA
Hansen Medical Inc
Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the cathete...
Cardiac Devices·59 affected·Dec 4, 2014
High RiskFDA
Ev3, Inc.
ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high r...
Medical Implants·14 affected·Dec 4, 2014
CriticalFDA
Giant Eagle, Inc.
Jumbo Lump Crab Cakes packed from bulk into clam shell containers with Giant Eagle scale label 100% Jumbo Lump Crab Cake Sell by D...
Seafood·30,000 affected·Dec 3, 2014
CriticalFDA
Hospira Inc.
MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg...
Injectable Drugs·13,792 affected·Dec 3, 2014
High RiskFDA
Hospira Inc.
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per...
Injectable Drugs·62,650 affected·Dec 3, 2014
High RiskFDA
Pfizer Inc.
Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactu...
Drugs·31,569 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. Patient positioning during surgery, ranging from...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
(R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119. Patient positioning during surgery, ranging f...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919. Patient positioning during surgery, ran...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Arjo Hospital Equipment Ab
TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of ...
Medical Devices·567 affected·Dec 3, 2014
CriticalFDA
Leonhard Lang Gmbh
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: ...
Cardiac Devices·1,080 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649. Patient positioning during surgery, ranging from ane...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-r...
Medical Devices·7 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during surgery, ranging from anesthe...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048. Patient positioning during surgery, ranging ...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Teleflex Medical
WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or...
Medical Devices·3,180 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854. Patient positioning during surgery, ranging fro...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915. Patient positioning during surgery, ranging fr...
Medical Devices·137 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. Patient positioning during surgery, ranging from a...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Innokas Medical Oy
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medic...
Medical Devices·20 affected·Dec 3, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed ...
Cardiac Devices·50 affected·Dec 3, 2014
High RiskFDA
Ferno-washington Inc
Ferno Model 35X PROFlexx Stretchers, one unit per package
Medical Devices·46 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333. Patient positioning during surgery, rangin...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Renew Life Formulas, Inc.
PureLife Naturals Adult Multi-Plus Multi-Vitamins & Minerals Plus Herbs, 60 Pure Caps HDPE bottle
Supplements·60,781 affected·Dec 2, 2014
CriticalFDA
House Of Flavors, Inc.
Dark Cocoa Sorbetto packed in 14 oz. plastic jars, 8 packages per case, manufactured from 4/11/14-4/12/14; product code: EB/JP, L3, 26-42...
Food·2,496 affected·Dec 2, 2014
CriticalFDA
Overhill Farms Inc
Open Nature Chile Cheese Enchilada Two enchiladas filled with a queso fundido cheese mix topped with guajillo sauce and Mexican chee...
Dairy·1,680 affected·Dec 2, 2014
High RiskFDA
Renew Life Formulas, Inc.
PureLife Naturals Multi-Action Immunity 90 Pure-Caps HDPE bottle
Food·55,271 affected·Dec 2, 2014
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP...
Medical Devices·8 affected·Dec 2, 2014
High RiskFDA
Biomet, Inc.
Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemente...
Medical Implants·9 affected·Dec 2, 2014
High RiskFDA
Biomet, Inc.
Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip ...
Medical Devices·8 affected·Dec 2, 2014